Alzheimer Disease, Mild Cognitive Impairment, Mild Memory Disturbance
Conditions
Keywords
Patient Distress, Caregiver Burden, Caregiver Stress, Mobile Phone Application, Psychological Symptoms, Behavioral Symptoms, Behavioral and Psychological Symptoms of Dementia, Neuropsychiatric Symptoms, mHealth, Mobile Health
Brief summary
The purpose of this research study is to learn whether it is possible and useful for caregivers to report behavioral or psychological symptoms of people with mild memory problems or Alzheimer's disease through a smartphone mobile application. The investigators believe that monitoring these symptoms and having a tool, like a mobile application, can provide quicker accessibility to the patient's clinical care team, which could improve care for patients and caregivers. These types of symptoms found in patients with mild memory problems or Alzheimer's disease are any type of psychiatric symptoms or abnormal behaviors one might develop as the result of these brain illnesses. Examples of psychological and behavioral symptoms are depression, anxiety, insomnia, irritability, agitation, and hallucinations. These symptoms differ from regular psychiatric symptoms, because they are caused by mild memory problems or Alzheimer's disease (AD). These symptoms can cause a lot of distress for patients and caregivers, and can lead to greater use of healthcare services.
Detailed description
As a part of this research study the patient and caregiver will undergo randomization, like flipping a coin, to assign the patient and caregiver to one of two research study groups. The patient and the partnered caregiver will join the same group. The group will either receive: 1) three in-person assessments on symptoms and behaviors that the patient may experience and a mobile application that will send surveys to the caregiver in order to rate the presence, severity and stress caused by these symptoms and behaviors; or 2) three in-person assessments on symptoms and behaviors that the patient may experience and no mobile application. The outcomes of these surveys and assessments will then be shared with the patient's clinical team. If the caregiver is assigned to the group that receives the mobile application they will receive the surveys either weekly or monthly. After each month of completing the surveys, the frequency will change. Depending on feedback from the first 10 participants, the investigators may modify the survey rate to happen more than weekly.
Interventions
OTHERMobile Phone Application Assessments
The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.
OTHERStandard Assessments
The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.
Sponsors
National Institute on Aging (NIA)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The principal investigator will be masked to arm allocation of participants. The outcomes assessor at time of 3 month and 6 month (final) assessment will also be masked to the allocation of participants.
Intervention model description
The study design includes six 1-month periods. Those in the intervention group will be nested in a 2 x 6 cross-over design in which they will be randomly assigned to start with 1 of 2 schedules of Ecological Momentary Assessment (EMA) surveillance frequency (1) weekly or (2) monthly. The intervention participants will then cross-over at the end of each and every month to the other surveillance frequency condition, over a 6-month time horizon.
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes
Inclusion criteria
* The patient: * Has Alzheimer's Disease (AD) or Amnestic Mild Cognitive Impairment (aMCI), is a Healthy Aging Brain Center, Eskenazi Health patient * Community dwelling * Has a legally authorized representative when they lack capacity to consent * The caregiver: * 18 or older * No visual impairment * Community dwelling * Reports seeing patient most days of the week
Exclusion criteria
* The patient: * History of mental illness (Schizoaffective disorder, schizophrenia, bipolar) * Participating in another study * The potential participant with a diagnosis of either aMCI or AD communicates observable dissent. * The caregiver: * History of mental illness (Schizoaffective disorder, schizophrenia, bipolar) * Participating in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months | Calculated at 6 months | Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, Dementia Collaborative Care- Caregivers did not utilize the BrainCare Notes application. |
| Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months | Calculated at 3 months | Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, Dementia Collaborative Care- Caregivers did not utilize the BrainCare Notes application. |
| Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months | Calculated at 3 months | — |
| Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months | Calculated at 6 months | — |
| Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint. | Measured at 6 months | The System Usability Scale (SUS) will be used to assess usability of the BrainCare Notes app at 6 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5 |
| Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint | Measured at 3 months | The System Usability Scale will be used to assess usability of the BrainCare Notes app at 3 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | Calculated at 6 months | The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity. |
| Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | Calculated at 3 months | The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity. |
| Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | Calculated at 6 months | The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity. |
| Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | Calculated at 3 months | The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | Calculated at 3 months | The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - Never to 4 Very often. Total scores range from 0 to 56 with a higher score indicating greater perceived stress. |
| Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | Calculated at 6 months | The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, 0 - Never to 4 - Nearly Always. Total scores range from 0 to 48 with a higher score indicating greater caregiver burden. |
| Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | Calculated at 3 months | The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, 0 - Never to 4 - Nearly Always. Total scores range from 0 to 48 with a higher score indicating greater caregiver burden. |
| Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | Calculated at 6 months | The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - Never to 4 Very often. Total scores range from 0 to 56 with a higher score indicating greater perceived stress. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dementia Collaborative Care - Patients Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's symptoms or the caregiver's distress answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. | 5 |
| Dementia Collaborative Care - Caregivers Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's symptoms or the caregiver's distress answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. | 5 |
| Dementia Collaborative Care Plus BrainCare Notes Application - Patients Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. | 5 |
| Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. | 5 |
| Total | 20 |
Baseline characteristics
| Characteristic | Dementia Collaborative Care - Patients | Dementia Collaborative Care - Caregivers | Dementia Collaborative Care Plus BrainCare Notes Application - Patients | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 5 Participants | 3 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Age, Continuous | 78.2 years | 64.4 years | 78.2 years | 70.6 years | 72.85 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 4 Participants | 4 Participants | 18 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 5 participants | 5 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 2 Participants | 3 Participants | 13 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 1 / 5 | 0 / 5 |
| serious Total, serious adverse events | 3 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months
Time frame: Calculated at 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - Dementia Collaborative Care - Caregivers | Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months | 3 Participants |
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months | 4 Participants |
Primary
Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months
Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, Dementia Collaborative Care- Caregivers did not utilize the BrainCare Notes application.
Time frame: Calculated at 3 months
Population: This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. There were only 4 randomized participants who reached this time point before the study was terminated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - Dementia Collaborative Care - Caregivers | Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months | 0 Participants |
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months | 4 Participants |
Primary
Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months
Time frame: Calculated at 6 months
Population: The study was terminated before other participants reached the 6 month time point. Two caregivers reached the 6 month time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months | 2 participants |
Primary
Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months
Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, Dementia Collaborative Care- Caregivers did not utilize the BrainCare Notes application.
Time frame: Calculated at 6 months
Population: This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. There were only two randomized participants that reached the 6 month time point before the study was terminated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - Dementia Collaborative Care - Caregivers | Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months | 0 Participants |
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months | 2 Participants |
Primary
Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint
The System Usability Scale will be used to assess usability of the BrainCare Notes app at 3 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5
Time frame: Measured at 3 months
Population: This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. The study was terminated before the other participant reached the 3 month time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint | 4 Participants |
Primary
Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint.
The System Usability Scale (SUS) will be used to assess usability of the BrainCare Notes app at 6 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5
Time frame: Measured at 6 months
Population: This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. The study was terminated before other participants reached the 6 month time point. Two caregivers reached the 6 month time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint. | 2 Participants |
Secondary
Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.
Time frame: Calculated at 3 months
Population: There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers.~The study was terminated before the other participant reached the 3 month time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control - Dementia Collaborative Care - Caregivers | Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | 0.33 score on a scale |
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | 1 score on a scale |
Secondary
Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.
Time frame: Calculated at 6 months
Population: The study was terminated before the other participants were able to complete this survey at the 6 month time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | 6 score on a scale |
Secondary
Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.
Time frame: Calculated at 3 months
Population: There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected as the study was terminated before reaching this time point.~The study was terminated before the other participant reached the 3 month time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control - Dementia Collaborative Care - Caregivers | Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | 0.33 score on a scale |
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | 4.25 score on a scale |
Secondary
Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.
Time frame: Calculated at 6 months
Population: The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | -3.5 score on a scale |
Other Pre-specified
Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - Never to 4 Very often. Total scores range from 0 to 56 with a higher score indicating greater perceived stress.
Time frame: Calculated at 3 months
Population: There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected because the study was terminated.~The study was terminated before the other participant reached the 3 month time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control - Dementia Collaborative Care - Caregivers | Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | -1 score on a scale |
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | -3.67 score on a scale |
Other Pre-specified
Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - Never to 4 Very often. Total scores range from 0 to 56 with a higher score indicating greater perceived stress.
Time frame: Calculated at 6 months
Population: The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point, data from the remaining participants wasn't collected.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | 3 score on a scale |
Other Pre-specified
Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, 0 - Never to 4 - Nearly Always. Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.
Time frame: Calculated at 3 months
Population: There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected as the study was terminated before the time point was reached.~The study was terminated before the other participant reached the 3 month time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control - Dementia Collaborative Care - Caregivers | Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | 1 score on a scale |
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | 0 score on a scale |
Other Pre-specified
Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, 0 - Never to 4 - Nearly Always. Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.
Time frame: Calculated at 6 months
Population: The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point, data from the remaining participants wasn't collected.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | -1 score on a scale |